Overview

This trial is active, not recruiting.

Condition right ventricular dysfunction
Sponsor Heidelberg University
Start date October 2010
End date December 2015
Trial size 150 participants
Trial identifier NCT01230294, S275-2010

Summary

Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
participants without structural heart disease
patients with chronic heart failure of the left ventricle affecting the right heart
patients with pulmonary arterial hypertension without left ventricular dysfunction

Primary Outcomes

Measure
3D-volumetry of the right ventricle
time frame: 2 years
2D strain of the right ventricle
time frame: 2 years

Secondary Outcomes

Measure
pulmonary artery systolic pressure (PASP)
time frame: 2 years
tricuspid annular plane systolic excursion (TAPSE)
time frame: 2 years
tricuspid annular systolic velocity (TASV)
time frame: 2 years
Tei-index (myocardial performance index)
time frame: 2 years
LV-eccentricity-index (Lei-index)
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - persons of 18 years and older who receive a transthoracic echocardiography at our department - written consent Exclusion Criteria: - present atrial fibrillation/flutter - permanent pacemaker rhythm - moderate/severe valvular heart disease - pregnancy

Additional Information

Official title Evaluation of New Echocardiographic Methods for Measurement of Right Ventricular Function.
Principal investigator Sebastian Greiner, M.D.
Description Studies of the last years revealed that the right ventricular function is an important predictive value for the survival of patients with congenital heart disease, pulmonary hypertension or chronic heart failure. In 2006 the National Heart, Lung and Blood Institute has pronounced the right ventricular dysfunction including the non-invasive assessment of the right ventricular function as preferential aim of cardiovascular research. Many parameters are used to describe right ventricular dysfunction, but none of these has a comparable significance like the left ventricular ejection fraction. Because of the limitation of each right ventricular parameter the stepwise combination of these parameters is used to describe right ventricular function what frequently results in further problems, especially in comparison of long-term controls. Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function. The study is carried out as prospective, monocentric trial at the Department of Cardiology of the University Hospital of Heidelberg. Three different groups are set up for the assessment of the right ventricular function: patients with pulmonary arterial hypertension, patients with chronic heart failure of the left ventricle affecting the right heart and patients without structural heart disease who underwent an echocardiographic examination for other reasons (control group). All participants are re-examined in constant intervals as clinically indicated.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Heidelberg University.